Health Canada has approved a new indication for Sanofi and Regeneron’s Dupixent (dupilumab injection), as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyposis (CRSwNP). 18 August 2020
Hyderabad, India-based Biological E Limited (BE) has announced the acquisition of Akorn India Limited, a subsidiary of US generics firm Akorn Inc, whose shares tumbled more that 15% to $0.11 following the news. 17 August 2020
Diabetes care giant Novo Nordisk today announced plans to invest 850 million Danish kroner ($135 million) in expanding its production facilities in Kalundborg, Denmark. 14 August 2020
Bushu Pharmaceuticals, one of Japan's largest contract manufacturers of pharmaceutical products, today announced a major capital program costing $100 million to expand its footprint, capacity and portfolio of services. 14 August 2020
Debiopharm has announced the release of compelling follow-up results from the Phase II study of Debio 1143 alongside chemo-radiation therapy (CRT) versus CRT alone in high-risk patients with locally advanced squamous cell carcinoma of the head and neck. 13 August 2020
Argentina and Mexico will produce the AstraZeneca COVID-19 vaccine for most of Latin America, Argentine President Alberto Fernandez said after a meeting with company executives involved in the project, according to a report by Expresspharma.india. 13 August 2020
F2G Ltd, a UK- and Austria-based biotech developing novel therapies for life-threatening systemic fungal infections, and a Novo Ventures portfolio company. has secured $60.8 million in new financing from new and existing investors. 12 August 2020
US biotech major Gilead Sciences says that the China National Medical Products Administration (NMPA) has approved a pre-exposure prophylaxis indication for Truvada (emtricitabine 200mg/tenofovir disoproxil fumarate 300mg, FTC/TDF). 11 August 2020
Anglo-Swedish pharma major AstraZeneca has entered into an agreement with Chinese vaccine manufacturer Shenzhen Kangtai to produce its COVID-19 vaccine candidate AZD1222, when approved, in China by the end of 2020. 10 August 2020
The US Food and Drug Administration has approved Lampit 00(nifurtimox) for use in pediatric patients (from birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi (T. cruzi). 8 August 2020
US pharma giant Pfizer's New Drug Application (NDA) for injectable antibiotic Zinforo (ceftaroline fosamil) did not get approval in China. 6 August 2020
US biotech Moderna revealed on Wednesday that smaller volume agreements for its investigational COVID-19 vaccine mRNA-1273 have been executed at between $32 and $37 per dose. or up to $74 for a full course. 6 August 2020
GentiBio, a biopharma company developing engineered regulatory T cells that restrict inflammation in specific tissues, announced today the launch of the company with $20 million seed funding from OrbiMed, Novartis Venture Fund and RA Capital Management. 5 August 2020
HUYA Bioscience, a global firm specializing in biopharma opportunities originating in China, has exclusively licensed global ex-China rights to the SHP2 inhibitor, HBI-2376. 4 August 2020
Californian firm IDEAYA Biosciences has announced the regulatory clearance of its collaboration partnership with GlaxoSmithKline, which includes an upfront cash payment of $100 million from GSK. 4 August 2020
The US Food and Drug Administration has approved the supplemental new drug application (sNDA) for Spravato (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. 3 August 2020
Singapore-based ASLAN Pharmaceuticals has appointed a new chief medical officer, Kenneth Kobayashi, formerly senior medical director at Eli Lilly subsidiary Dermira. 3 August 2020
The US Food and Drug Administration on Friday approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. 1 August 2020
Japanese drugmaker Eisai and Merck & Co’s subsidiary MSD KK announced today that Eisai has submitted an application in Japan for the additional indication of treatment of unresectable thymic carcinoma for multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib mesylate). 31 July 2020
Trevi Therapeutics has announced significant milestones in its clinical programs for Haduvio (nalbuphine), an investigational therapy aimed at treating chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). 4 October 2024
Italian pharma major Recordati saw its shares rise more than 5% to 52.00 euros in early trading, as it announced a deal to expand its portfolio of marketed rare disease medicines. 4 October 2024
Paris-based asset manager Kurma Partners has raised 140 million euros ($154 million), successfully completing the first closing of Biofund IV 4 October 2024
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
Opioid Use Disorder (OUD) is a chronic neurological disorder that is described as the consequences associated with repeated, compulsive use of opioid drugs and prolonged self-administration of opioid drugs. 4 October 2024
Proposals from the National Health Service (NHS) England have been set out for a phased launch of Eli Lilly’s obesity injection Mounjaro/Zepbound (tirzepatide) at the start of a consultation. 4 October 2024
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024
Bristol Myers Squibb has received a new approval from the US Food and Drug Administration for its blockbuster checkpoint blocker, Opdivo (nivolumab). 4 October 2024
Singapore’s Agency for Science, Technology and Research (A*STAR) and US biotech incubator Flagship Pioneering have agree to collaborate on advancing health and sustainability outcomes in Singapore and the broader Asia Pacific region. 4 October 2024
The US Food and Drug Administration (FDA) has removed the partial clinical hold on delpacibart etedesiran (del-desiran/AOC 1001), an investigational treatment designed to address the root cause of myotonic dystrophy type 1 (DM1), under development by US biotech Avidity Biosciences . 4 October 2024
F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic. 3 October 2024
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
The US Food and Drug Administration (FDA) has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. 3 October 2024
Israel’s Teva Pharmaceutical Industries and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, have announced a global licensing deal for the development of an anti PD-1 oncology biosimilar candidate. 3 October 2024
Caliway Biopharmaceuticals has successfully completed its initial public offering, raising NT$6.4 billion ($206 million), the largest IPO in Taiwan's biotech industry to date. 3 October 2024
Kedrion Biopharma has finalized an agreement with Germany-based Biotest for the long-term commercialization and distribution of Yimmugo (immune globulin) in the USA. 3 October 2024
US clinical-stage biotech Arcus Biosciences has entered into a clinical trial collaboration with AstraZeneca on renal cancer treatments. 3 October 2024
PeptiDream says that its wholly-owned PDRadiopharma subsidiary has entered into a strategic partnership with French nuclear medicines firm Curium. 3 October 2024